Země: Filipíny
Jazyk: angličtina
Zdroj: FDA (Food And Drug Administration)
Getryl
N/A; Importer: Getz Pharma (Phils.), Inc.; Distributor: N/A
Getryl
3mg
Tablet
Alu-Alu Blister x 10's (Box of 20's), Alu-Alu Blister Pack x 10's (box of 20's)
Getz Pharma (Pvt.) Ltd., Pakistan
Anti-Diabetic
As an adjunct to diet and exercise to lower blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.
2021-05-17
DESCRIPTION Glimepiride (Getryl ® ) is an oral blood glucose lowering drug of the sulfonylurea class. Chemically glimepiride is 1-[[p-[2-(3-Ethyl-4-methyl- 2-oxo-3-pyrroline-1-carboxamido) ethyl]phe nyl]-sulphonyl]-3-(trans-4- methylcyclohexyl)urea. The molecular formula is C 24 H 34 N 4 O 5 S and the structural formula is: FORMULATION Glimepiride (Getryl ® ) is available for oral administration as: 1. Glimepiride (Getryl ® ) Tablets 1mg Each tablet contains: Glimepiride…1mg 2. Glimepiride (Getryl ® ) Tablets 2mg Each tablet contains: Glimepiride…2mg 3. Glimepiride (Getryl ® ) Tablets 3mg Each tablet contains: Glimepiride…3mg 4. Glimepiride (Getryl ® ) Tablets 4mg Each tablet contains: Glimepiride…4mg CLINICAL PHARMACOLOGY MECHANISM OF ACTION The primary mechanism of action of glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. In addition, extra-pancreatic effects (e.g. reduction of basal hepatic glucose production and increased peripheral tissue sensitivity to insulin and glucose uptake) may also play a role in the activity of glimepiride. However, as with other sulfonylureas, the mechanism by which glimepiride lowers blood glucose during long-term administration has not been clearly established. PHARMACOKINETICS After oral administration glimepiride is completely absorbed from the GI tract. The oral bioavailability is approximately 100%. Peak plasma concentrations occur in 2-3 hours. More than 99% of the drug is bound to plasma proteins. Glimepiride is completely metabolized by oxidative biotransformation into two main metabolites, a hydroxy derivative and a carboxy derivative. The elimination half-life (t 1 / 2 ) after multiple doses is about 5-8 hours. Approximately 60% of dose is eliminated in the urine and 40% in the feces. SPECIAL POPULATIONS _Renal Insufficiency_ A single-dose clinical study glimepiride showed that glimepiride serum levels decreased as renal function decreased. However, metabolite serum levels (mean AUC values) i Přečtěte si celý dokument